NL-OMON52593已完成3 期
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer - CA209-7F
Bristol-Myers Squibb0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Participants must have histologically confirmed unilateral invasive breast
- •carcinoma, with the following characteristics (i, ii, iii):
- •i) Localized invasive breast ductal carcinoma, confirmed by the local
- •pathologist, that includes T1c-T2, clinical node stage (cN)1-cN2, or T3 T4,
- •cN0-cN2. Inflammatory breast cancer is allowed.
- •ii) Participants must have ER+, HER2- BC meeting below characteristics (1,2):
- •(1)ER+ breast cancer and with or without progesterone-receptor (determined by
- •central laboratory as defined in the relevant American Society of Clinical
- •Oncology [ASCO]-College of American Pathologists [CAP] Guidelines).
- •(2)HER2- breast cancer tested in a local laboratory defined as a negative in
- •situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+
- •(determined by local laboratory as defined in the relevant ASCO- CAP
- •Guidelines).
- •iii)Participant must have Protocol-specified disease grade 2 or 3 according to
- •the most recent ASCO-CAP guidelines.
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) scale
- •performance status of 0 or 1.
- •Participants provide tumor tissue at baseline (collected <= 60 days prior to
- •enrollment) and at surgery.
- •Women of childbearing potential (WOCBP) must have a negative serum or urine
- •pregnancy test within 24 hours prior to the start of study treatment.
- •Participants must have signed and dated an Institutional Review Board
- •(IRB)/Independent Ethics Committee (IEC)-approved written ICF, in accordance
- •with regulatory and institutional guidelines
排除标准
- •Women who are breastfeeding
- •Participants who are pregnant or expecting to conceive or father children
- •during the study, starting with the screening visit through 12 months for
- •patients who receive cyclophosphamide, or 7 months for patients who do not
- •receive cyclophosphamide, after the last dose of study treatment.
- •The following Breast Cancer (BC) characteristics:
- •- Ipsilateral invasive BC, Inoperable BC, Multicentric BC, Bilateral invasive
- •BC, ipsilateral ductal carcinoma in situ treated with radiation, or
- •contralateral invasive BC, at any time.
- •- Definitive clinical or radiologic evidence of metastatic disease.
- •- Any of the following clinical lymph node staging: cN3, cN3a, cN3b, or cN3c
- •- History of ductal carcinoma in situ
- •- History of pleomorphic lobular carcinoma in situ
- •- Evidence of ER- BC
- •- Undergone excisional biopsy of the primary tumour and/or axillary lymph
- •nodes or has undergone sentinel lymph node biopsy
- •Patients with >= Grade 1 peripheral neuropathy.
- •Patients with an active, known, or suspected autoimmune disease. Participants
- •with type I diabetes mellitus, hypothyroidism only requiring hormone
- •replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not
- •requiring systemic treatment, or conditions not expected to recur in the
- •absence of an external trigger are permitted to enroll.
- •Participants with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other
- •immunosuppressive medications within 30 days of randomization. Inhaled or
- •topical steroids, and adrenal replacement steroid doses > 10 mg daily
- •prednisone equivalent, are permitted in the absence of active autoimmune
- •Known human immunodeficiency virus (HIV) positive with an acquired
- •immunodeficiency syndrome (AIDS).
- •Prior malignancy active within the previous 3 years, except for locally
- •curable cancers that have been apparently cured.
- •Participants with serious or uncontrolled medical disorders.
- •Other non-malignant systemic disease that would preclude the participant
- •from receiving study treatment or would prevent required follow-up.
- •Active infection or chronic infection requiring chronic suppressive
- •antibiotics.
- •Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease,
- •resection of the stomach or small bowel, or other disease or condition
- •significantly affecting gastrointestinal function.
- •Any psychological, familial, sociological, or geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule.
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4
- •antibody, or any other antibody or drug specifically targeting T-cell
- •co-stimulation or checkpoint pathways.
- •Any treatment, local or systemic, including prior chemotherapy, Endocrine
- •Therapy (ET), targeted therapy, and/or radiation therapy for the currently
- •diagnosed BC prior to enrollment.
- •Concurrent use of hormone replacement therapy, hormonal contraception or any
- •other estrogen-containing medication.
- •Surgical axillary staging procedure prior to enrollment (with the exception
- 另有 2 项未显示
研究者
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